UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044441 |
|---|---|
| Receipt number | R000050764 |
| Scientific Title | The prospective study to evaluate the technical feasibility and clinical effectiveness of endoscopic ultrasounds-guided hepaticogastrotomy with small diameter guide wire. |
| Date of disclosure of the study information | 2021/06/07 |
| Last modified on | 2021/12/16 09:45:16 |
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Basic information
Public title
The prospective study to evaluate the technical feasibility and clinical effectiveness of endoscopic ultrasounds-guided hepaticogastrotomy with small diameter guide wire.
Acronym
The prospective study to evaluate the technical feasibility and clinical effectiveness of endoscopic ultrasounds-guided hepaticogastrotomy with small diameter guide wire.
Scientific Title
The prospective study to evaluate the technical feasibility and clinical effectiveness of endoscopic ultrasounds-guided hepaticogastrotomy with small diameter guide wire.
Scientific Title:Acronym
The prospective study to evaluate the technical feasibility and clinical effectiveness of endoscopic ultrasounds-guided hepaticogastrotomy with small diameter guide wire.
Region
| Japan |
Condition
Condition
Obstructive jaundice
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of usefulness and safety of EUS-HGS using a guide wire with a smaller diameter than the conventional one
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
technical success
Key secondary outcomes
early/rate adverse event
clinical effect improvement rate
stent patency
time to stent dysfunction
survival rate
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
The cases of EUS-HGS using 0.018 inch guidewire
The number of procedure is 1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 95 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.20 years old and over
2.Cases with obstructive jaundice for which transpapillary biliary drainage is difficult
3.Cases of biliary calculus with difficult transpapillary biliary drainage
4.Intrahepatic bile duct is 1.5 mm or less
5.ECOG (Eastern Cooperative Oncology Group) performance status 0-3
Key exclusion criteria
1.Cases with serious complications in other organs: 3 or more in ASA classification (excluding dialysis patients)
2.ECOG performance status 4
3.When the prognosis for life is judged to be less than 3 months due to poor general condition
4.Other patients who are judged by the research-responsible (sharing) doctor to be inappropriate as subjects
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Okuda |
Organization
Osaka Medical and Pharmaceutical University
Division name
2nd Department of Internal Medicine
Zip code
5698686
Address
2-7,Daigakummachi,Takatsuki city,Osaka
TEL
0726831221
atsushi.okuda@ompu.ac.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Okuda |
Organization
Osaka Medical and Pharmaceutical University
Division name
2nd Department of Internal Medicine
Zip code
5698686
Address
2-7,Daigakummachi,Takatsuki city,Osaka
TEL
0726831221
Homepage URL
atsushi.okuda@ompu.ac.jp
Sponsor or person
Institute
Osaka Medical and Pharmaceutical University
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical and Pharmaceutical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Medical and Pharmaceutical University
Address
2-7,Daigakummachi,Takatsuki city,Osaka
Tel
09020676363
ubuntu_koromo@yahoo.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 06 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 02 | Month | 07 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 28 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 06 | Month | 05 | Day |
Last modified on
| 2021 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050764
